Kornimate/medical-research-clean huggingface dataset:
randomized evaluation of strategic intervention in multidrug resistant patients with tipranavir (resist)

Conditions: HIV Infections

Summary: demonstrate the safety and efficacy of tipranavir/ritonavir versus an active treatment regimen in highly treatment experienced human immunodeficiency virus 1(hiv-1) infected patients.


Eligibility criteria:
inclusion criteria: patients meeting the following criteria will be eligible for participation in th is study: 1. human immunodeficiency virus 1 (hiv-1) infected males or females \>=18 years of age. 2. screening genotypic resistance report indicating both of the following: at least one primary protease inhibitor (pi) mutation at the following sites: 30n, 46i/l, 48v, 50v, 82a/f/l/t, 84v or 90m, and no more than two protease mutations on codons 33, 82, 84, or 90. 3. at least 3 consecutive months experience taking antiretrovirals (arvs) from each of the classes of nucleoside reverse transcriptase inhibitors(nrti(s)), non-nucleoside reverse transcriptase inhibitors(nnrti(s)), and protease inhibitors (pis) at some point in treatment history,with at least 2 protease inhibitor (pi)-based regimens, one of which must be the current regimen, and current protease inhibitor (pi)-based antiretroviral (arv) medication regimen for at least 3 months prior to randomization. 4. human immunodeficiency virus 1 (hiv-1) viral load \>=1,000 copies/ml at screening. exclusion criteria: patients with any of the following criteria are excluded from participation in t he study: 1. antiretroviral (arv) medication naïve. 2. patients on recent drug holiday, defined as off antiretroviral (arv) medications for at least 7 consecutive days within the last 3 months. 3. alanine aminotransferase (alt) \>=3.0x upper limit of normal (uln) and aspartate aminotransferase(ast) \>=2.5x upper limit of normal (uln) (\>=division of aids(daids) grade 1) at either screening visit.
diaphragmatic height index: the new diagnostic test for phrenic nerve dysfunction

Conditions: Respiratory Paralysis

Summary: diaphragmatic contraction is controlled by phrenic nerve which consists of anterior rami of 3rd- 5th cervical nerve roots. usually, it can't be evaluated from history taking and physical examination. thus the diaphragmatic elevation on chest radiograph is assumed to identify the phrenic nerve dysfunction. normally, the right diaphragm is higher than the left side about 1.5 ± 0.9 centimeters or 0.5 ± 0.3 time of vertebral height. although there are several methods to determine the diaphragmatic elevation from previous studies, the accuracy, reliability, intra and inter-observer variation are problem. neurotization is the effective procedure to restore upper extremity function in root avulsion type. phrenic nerve is one of the common donor nerves which used for this procedure. but sometimes, concomitant injury of this nerve can occur. therefore, the investigators established "diaphragmatic height index (dhi)" from chest radiograph to use as the diagnostic test for phrenic nerve dysfunction.


Eligibility criteria:
inclusion criteria: * brachial plexus injured patients who underwent the neurotization in our institute between 2005-2008 * non brachial plexus injured patients who underwent the other orthopedic operation in our institute between april-june 2009 exclusion criteria: * concomitant pneumothorax and/or hemothorax * concomitant pulmonary contusion * previous pulmonary disease * chest wall deformity * thoracic or thoracolumbar scoliosis (\>10 degrees) * hepatomegaly * incomplete data
impact of intraoperative cell salvage

Conditions: Peripartum Anemia

Summary: patients presenting for elective cesarean section will be screened for pre-procedural anemia. if the potential subject meets the selection criteria they will be presented with the option of participating in the study. once consented the participant is randomized by envelope. the two groups studied are: standard of care with intraoperative cell salvage and standard of care without cell salvage. if the participant is randomized to the cell salvage group, the study team will notify the anesthesia and obstetrics (ob) team and will set up the cell salvage system per protocol. the primary end point is to determine the difference in postoperative hemoglobin at 48hrs, need and quantity of allogeneic blood product transfusion, length of hospital stay between the two groups studied. the secondary endpoints investigate the impact of using iocs on clinical parameters associated with maternal postpartum stability and well being and include estimation of blood loss, need for pressors, uterotonics, return to the operating room, uterine compression devices, icu admission, postoperative blood product transfusion, iv iron supplementation, blood chemistry, coagulation parameters, oliguria, diagnosis of acute kidney injury, postoperative dialysis, acute respiratory distress syndrome, pulmonary edema, pneumonia, deep vein thrombosis, pulmonary embolism, oxygen requirement, new arrythmias apgar scores, anemia fatigue scale at 24hr and 48 hrs, obsqor10 score 24 hours and 48 hours postpartum and 6 week postpartum epds score.


Eligibility criteria:
inclusion criteria: * women aged 18-55 years. * presenting for elective cesarean section. * with hemoglobin less or equal to 11 mg/dl. * able to provide informed written consent. exclusion criteria: * refusal of blood product administration. * refusal of intraoperative blood salvage.
study of an investigational glucose meter system

Conditions: Diabetes

Summary: the purpose of this study is to demonstrate that untrained subjects who have diabetes can operate the investigational blood glucose monitoring system (bgms) and obtain valid glucose results.


Eligibility criteria:
inclusion criteria: * males and females, 18 years of age and older * type 1 or type 2 diabetes * able to speak, read, and understand english * willing to complete all study procedures exclusion criteria: * pregnancy * hemophilia or any other bleeding disorder * previously participated in a study using the g3 system * working for a medical laboratory, hospital or other clinical setting that involves training on and clinical use of blood glucose monitors. * a condition, which in the opinion of the investigator, would put the person or study conduct at risk (reason for exclusion will be clearly documented by investigator or designee). * working for a competitive medical device company, or having an immediate family member or someone who is not a family member but is living within the household of someone who works for such a company.
celecoxib versus diclofenac in the treatment of osteoarthritis of the hip

Conditions: Osteoarthritis, Hip

Summary: to determine if celecoxib 200 mg once daily is as effective as diclofenac 50 mg three times daily in the treatment of pain symptoms associated with osteoarthritis of the hip


Eligibility criteria:
inclusion criteria: * diagnosed with osteoarthritis of hip and requiring joint replacement * eligible for chronic therapy with an nsaid exclusion criteria: * hip surgery anticipated within 8 calendar weeks after first visit * active gastrointestinal disease or recent diagnosis of gastrointestinal ulceration (within 60 days of first visit)
lactation education study in mothers of very low birth weight infants

Conditions: Infant, Very Low Birth Weight; Lactation

Summary: this study will test the effectiveness of breast milk expression discharge instructions in digital video disc (dvd) format for home use by mothers of very low birth weight infants on the dose and duration of mother's breast milk feeding in their infants compared to breast milk expression discharge instructions in printed format. the investigators hypothesize that infants whose mothers receive breast milk expression discharge instructions via dvd will receive a larger dose of maternal breast milk and for longer duration during the initial neonatal intensive care unit hospitalization than infants whose mothers receive discharge instructions in printed format.

very low birth weight (vlbw; \<1500 g) infants who receive maternal breast milk, as opposed to infant formula, are less likely to experience the serious illnesses and poor developmental outcomes associated with vlbw. however, a disparity exists in breast milk feeding. infants whose mothers have low educational attainment and low income are less likely to receive maternal breast milk than infants whose mothers who do not have low educational attainment and low income. the primary objective of this proposed research is to determine the effect of lactation discharge instructions in an audio-visual format provided to mothers for home viewing on the dose and duration of maternal breast milk received by their vlbw infants during the neonatal intensive care unit hospitalization. methods. forty mothers of vlbw infants will be randomly assigned to receive a breast milk expression instruction digital video disc (dvd) in addition to standard of care lactation education or assigned to receive written instructions in addition to standard of care lactation education. in addition to comparing infant intake of maternal breast milk intake, pre and post intervention lactation and breast milk expression knowledge will be compared between groups and dvd viewing frequency and acceptability will be determined with a log and questionnaire to be completed by the intervention group and collected the first month after delivery.

Eligibility criteria:
inclusion criteria: * infant birth weight less than 1500 grams * maternal educational attainment less than/equal to 12 years * maternal low income status (medicaid participant prior to delivery) exclusion criteria: * non-english speaking * illicit drug use during pregnancy

Keywords: breast milk feeding prematurity low birth weight infant low maternal breast milk feeding
villagewhere: innovative mobile technology for youth with conduct disorder and their parents

Conditions: Child Behavior Disorders

Summary: the goal of this phase ii small business innovation research (sbir) is to develop, evaluate, and commercialize a linked parent-youth mobile app system, villagewhere, to support the key treatment targets of evidence-based treatments for youth with conduct disorders: clear parental expectations, parental monitoring, discipline consistency, and parental support, while simultaneously cultivating intrinsic motivation in youth toward prosocial behaviors. when used in conjunction with an evidence-based treatment for delinquent youth, villagewhere could help reduce treatment length and cost. when provided in non-evidence-based clinical settings, villagewhere may increase access to state-of-the-art clinical techniques to those who might not otherwise receive them. investigators will conduct usability and acceptability tests of new features with target-end-users (youth and their parents) and key stakeholders (i.e., probation officers, clinic administrators). once usability and acceptability is achieved, investigators will conduct a 16-week randomized controlled trial (rct) comparing villagewhere to an attention-control (placebo) mobile app. we expect that across four time points, villagewhere use will result in greater improvements in parent management practices and youth autonomy support, parent-youth communication and connectedness, youth intrinsic motivation for positive behavior, and youth conduct problems than the placebo. the rct will occur with 100 parent-youth dyads recruited from various treatment and probation settings, and represent clinically-significant conduct-problems of various clinically-significant severity levels.


Eligibility criteria:
parent inclusion criteria: * english speaking * owns an android or iphone-based smartphone with a data plan, is the primary user of the phone, and uses it on a daily basis * primary caregiver and has legal guardianship (custody) of a youth aged 13-18 with conduct disorder. parent exclusion criteria: * has an open case with child protective services * does not have legal custody of the youth * participated in phase i project and/or the phase ii formative evaluation youth inclusion criteria: * english speaking * possesses and is the primary user of an android or iphone-based smartphone with a data plan * resides in the same household as the linked parent participant at least five days a week * actively (past two weeks) engaging in clinically significant conduct-problem behaviors note: youth who have "stepped down" from a residential treatment or juvenile justice facility in the past month but may not have exhibited conduct problem behavior within the past 2 weeks will also be eligible, provided other criteria are met. youth exclusion criteria: * resides with a secondary caregiver 3 or more days each week

Keywords: criminal justice juvenile delinquency
dexamethasone at night vs at induction on ponv after laparoscopic cholecystectomy

Conditions: Postoperative Nausea and Vomiting; Postoperative Pain; Laparoscopic Cholecystectomy

Summary: since the peak effect of the dexamethasone is delayed to 12-16 hours after iv administration, we designed this study to investigate the effect of administering dexamethasone at-night before surgery versus at-induction (the standard timing) in prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy. a pilot randomized controlled study (60 cases) will be started to explore the potential difference, ensure correct and rigorous data collection, and calculate the sample size for a larger pragmatic trial.

background: postoperative nausea and vomiting (ponv) are common complications after laparoscopic cholecystectomy. the aim of this study is to evaluate the efficacy of administration of prophylactic dexamethasone 12-hours prior to induction of anesthesia in preventing ponv after elective laparoscopic cholecystectomy, as it reaches its peak effect at 2-12 hours and lasts for 72 hours after intravenous (iv) administration. methods: this is a parallel two-arm, randomized (1:1), double-blind, controlled, single-center trial. adults (≥18 years) with american society of anesthesiology (asa) physical status i-iii scheduled for elective laparoscopic cholecystectomy will be eligible for inclusion. the participants will be randomized to receive either 8 mg iv dexamethasone at time of induction of anesthesia or 8 mg iv dexamethasone at 12 hours prior to induction of anesthesia. the primary outcome will be the incidence of postoperative nausea and vomiting. a total of 60 patients will be recruited as a pilot study.

Eligibility criteria:
inclusion criteria: * all consecutive adults (older than 18 years) with asa physical status i-iii undergoing elective laparoscopic cholecystectomy surgery at gastrointestinal surgery center. exclusion criteria: * patient refusal * use of steroids or antiemetic agents within 1 week of surgery * chronic opioid therapy * history of allergy to any study medications * serum creatinine \> 1.4 mg/dl * liver enzymes more than triple normal limits * pregnancy * psychiatric or neurologic diseases or socioeconomic status that would hinder postoperative quality of recovery questionnaire * patients whose laparoscopic surgery is converted to open surgery after enrollment will be excluded.
the role of hyperoxia in acute ischemic stroke

Conditions: Stroke, Acute

Summary: this study is being conducted to evaluate the potential therapeutic role of hyperoxia when applied in the immediate ischemic period following a stroke in the controlled emergency department setting. the study will evaluate the effects of hyperoxia in stroke patients on the production of markers of free radical damage and inflammatory markers associated with hyperoxic lung injury.


Eligibility criteria:
inclusion criteria: 1. provision of signed and dated informed consent form from patient or legal authorized representative (lar) 2. subject or lar stated willingness to comply with all study procedures and availability for the duration of the study 3. males and females (of unlikely childbearing capacity) aged over 18 years. 4. exhibiting signs and physical examination findings suggestive of an acute ischemic infarction (either a or b) 1. a target mismatch profile of ct-perfusion or mri determined by rapid automated software to have a ratio of pwitmax\>6 lesion volume/dwi lesion volume \>1.2 and an nihss \>/=1 2. a rapid automated software calculated non-contrast ct-head aspect score of 10 and lkw ≤12 hours (in patients with symptoms discovered upon waking, the lkw is defined at the midpoint between going to sleep and awakening based on previous studies that suggest most strokes during sleep occur close to awakening) 5. normoxic; a pulse oximetry of 94% or greater at time of screening without the use of supplemental oxygen exclusion criteria: 1. current use of supplemental oxygen 2. prisoner 3. documented blood glucose \<70mg/dl 4. concurrent treatment with another investigational drug or other intervention 5. documented history of any of the following chronic respiratory illness that require pulmonary vasodilators or supplemental oxygen at baseline: chronic obstructive pulmonary disorder (copd), emphysema, interstitial lung disease, restrictive lung disease, pulmonary hypertension 6. documented history of any of the following autoimmune diseases: systemic lupus erythematosus, rheumatoid arthritis, scleroderma, primary biliary cholangitis, multiple sclerosis, inflammatory bowel disease 7. currently being treated for an acute myocardial infarction and/or decompensated heart failure at the onset of initial ed presentation as reported by the ed provider 8. plans for treatment with either iv tpa (alteplase) or endovascular therapy
furosemide stress test guiding initiation of renal replacement therapy

Conditions: Acute Kidney Injury

Summary: does early initiation of renal replacement therapy have an impact on 7-day fluid balance in critically ill patients with acute kidney injury with positive furosemide stress test?: a multicenter randomized controlled trial

the objective is to determine if early initiation of renal replacement therapy guided by positive furosemide stress test has an impact on 7-day fluid balance in critically ill patients with acute kidney injury

Eligibility criteria:
inclusion criteria: * age older than 18 years old and admission in an icu * acute kidney injury (defined by serum creatinine increase ≥ 0.3 mg/dl or urine output ≤ 0.5 ml/kg/hour according to kdigo criteria) * informed consent provided by the patient or person with decisional responsibility * indwelling bladder catheter * documented cause of acute kidney injury from acute tubular necrosis e.g. presence of granular or epithelial casts on urine sediment, fena more than 1%, feurea more than 50%, urine or plasma neutrophil gelatinase-associated lipocalin (ngal) more than 150 mg/dl * opinion of the treating clinical team that patient was well resuscitated and sufficiently clinically stable for the intervention or by noninvasive or invasive measurements i.e. fluid accumulation at least 5% plus at least one of the following e.g. chest radiography, central venous pressure ≥ 8 mmhg, pulse pressure variation \< 13%, inferior vena cava collapsibility index \< 50% in spontaneously breathing patients or distensibility index \< 18% in mechanically ventilated patients exclusion criteria: * baseline serum creatinine ≥ 2 mg/dl (male) and ≥ 1.5 mg/dl (female) within 3 months * evidence of volume depletion at the time of furosemide administration or active bleeding * evidence of obstructive uropathy, renal vein thrombosis or renal artery stenosis, thrombotic microangiopathy, glomerulonephritis, tumor lysis syndrome * history of renal allograft * known pregnancy * allergy or known sensitivity to loop diuretics * need for emergency renal replacement therapy at randomization or evaluation by the clinical team that the renal replacement therapy should be deferred * patient is moribund with expected death within 24 hr or whom survival to 28 days is unlikely due to an uncontrollable comorbidity (cardiac, pulmonary or hepatic end-stage disease; hepatorenal syndrome; poorly controlled cancer; severe post-anoxic encephalopathy; etc.) * patients with advance directives issued expressing the desire not to be resuscitated * prior treatment with rrt within 30 days

Keywords: acute kidney injury furosemide stress test critical care
docetaxel followed by radical prostatectomy in patients with high risk localized prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this research study is to determine if the combination of chemotherapy and hormone therapy is safe and helpful for patients who plan to have their high-risk prostate cancer surgically removed. some physicians believe that patients with high risk cancer that is located in one area, may have an early but small spread of the cancer outside of the prostate, and perhaps even to distant organs. therefore, better treatments for the entire body are needed to improve the ability of surgery or other local therapies to cure prostate cancer. since chemotherapy is beginning to demonstrate increasing activity in advanced prostate cancer patients, it is possible that using chemotherapy combined with hormonal therapy earlier in the course of localized but high risk patients might improve the outcomes for these patients.

* participants will receive treatment in the outpatient clinic, where the docetaxel chemotherapy will be placed in a bag of fluid and will be given by vein every three weeks. participants will take decadron (dexamethasone) by mouth 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel. they will also take estramustine and casodex by mouth at home. zoladex (or lupron) will be given subcutaneously (under the skin) 4 times every three months. they will also be started on coumadin beginning at the time of the first docetaxel infusion and continuing until 3 weeks after the 4th cycle of chemotherapy. * after 2 months (or cycles) of therapy, participants will be evaluated in order to assess the response and toxicity of treatment, including a review of medical history, physical examination, blood tests, including psa. if there is no evidence of progression or excessive toxicity, treatment will continue for 2 more months in the same manner. * at the end of 4 months of chemotherapy, participants will be reassessed by the medical oncologist and urologist regarding surgery to remove the prostate.

Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the prostate * potential candidate for radical prostatectomy * any of the following: a) clinical stage t3 patients, b) serum psa greater than or equal to 20 ng/ml, c) gleason score 8-10, d) clinical t2 disease and either mri evidence of seminal vesicle involvement or gleason 4+3 cancer with either 5 or 6 biopsies positive * ecog performance status 0-1 * wbc \> 3,000 ul * hct \> 30% * plt \> 100,000/ul * lfts within normal limits exclusion criteria: * prior hormones, radiation or chemotherapy for prostate cancer * myocardial infarction within 1 year, significant change in anginal pattern within last 6 months, current congestive heart failure (nyha class 2 or higher), or deep venous thrombosis within 1 year * evidence of active infection * significant peripheral neuropathy

Keywords: prostatectomy docetaxel